UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034418 |
|---|---|
| Receipt number | R000039245 |
| Scientific Title | The state of birth preparation and its impact on physical and mental health after giving birth |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/04/14 16:31:11 |
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Basic information
Public title
The state of birth preparation and
its impact on physical and mental health after giving birth
Acronym
Development for evaluation measures about the state of birth preparation
Scientific Title
The state of birth preparation and
its impact on physical and mental health after giving birth
Scientific Title:Acronym
Development for evaluation measures about the state of birth preparation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The birth preparation state scale to prove its reliability and validity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The factor affects the birth preparation state
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Saliva collection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
low risk pregnant and parturient women
Key exclusion criteria
High risk pregnant and parturient women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fujiko |
| Middle name | |
| Last name | Omine |
Organization
University of The Ryukyus Faculty of Medicine
Division name
Department of Health science
Zip code
903-0215
Address
207 Uehara Nishihara-Town Okinawa
TEL
098-895-3331
Omine-f@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Takemoto |
Organization
University of The Ryukyus Faculty of Medicine
Division name
Department of Health science
Zip code
903-0215
Address
207 Uehara Nishihara-Town Okinawa
TEL
098-895-3331
Homepage URL
K168872@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
University of The Ryukyus Faculty of Medicine Department of Health science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of The Ryukyus Faculty of Medicine Department of Health science
Address
207 Uehara Nishihara-Town Okinawa
Tel
098-895-3331
Omine-f@med.u-ryukyu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039245
